Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

FDA ANNOUNCES BLACK BOX WARNING ADDITIONS FOR APTIVUS

German drugmaker Boehringer Ingelheim and the FDA have announced updates
to the black box warning for Aptivus, a treatment for HIV, after it was linked
to multiple fatal cases of brain hemorrhaging.

A recent letter to healthcare providers, distributed through the FDA's MedWatch
program, said that Aptivus (tipranavir) was linked to 14 events of intracranial
hemorrhaging (ICH), including eight fatalities, out of 6,840 HIV-1 infected
individuals taking the drug.

The black box warning urges doctors to be cautious in prescribing Aptivus,
which is co-administered with Abbot's Norvir, particularly for patients with
chronic hepatitis B or hepatitis C co-infections.

Many of the patients experiencing ICH suffered from other medical conditions
or were taking other drugs that may have caused or contributed to these events,
the letter said. In higher doses and in extreme cases, Aptivus treatment led
to bleeding in multiple organs and death.